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W L Gore & Associates, Inc. Recall 88721

Description: Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

W L Gore & Associates, Inc. Recall 88721 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0077-2022
Event ID88721
Event DescriptionHeparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
Product TypeDevices
DistributionInternational distribution to the countries of Italy & Lebanon.
Quantity2 units
Recall ReasonIncorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Device Classification20211020
Device Code InfoSerial Numbers: 22753580
Center Classification Date20211008
Recall Initiation Date20210907
Recalling FirmW L Gore & Associates, Inc.
Initial Notification E-Mail
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